A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00234403
• Other study ID #: 1839IL/0141
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2005
• Last updated: April 22, 2009
• Start date: May 2004
• Est. completion date: October 2007

Study information

• Verified date: April 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed advanced or metastatic breast cancer

• postmenopausal females with amenorrhoea > 12 months and an intact uterus

• FSH levels within postmenopausal range or have undergone a bilateral oophorectomy

• ER &/or PR positive

• previous adjuvant hormone therapy > 12 months prior to enrolment

• previous adjuvant chemotherapy > 6 months prior to enrolment

• measurable disease according to RECIST and/or non measurable bone disease

• life expectancy of at least 12 weeks

• World Health Organisation (WHO) performance status (PS) of 0 to 1.

Exclusion Criteria:

• Male

• life-threatening metastatic visceral disease

• evidence of clinically active interstitial lung disease

• ER and PR negative

• treatment with LHRH analogues < 3 months prior to enrolment

• patients who have restarted menses or do not have FSH levels within the postmenopausal range

• treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3 months

• Treatment with hormonotherapy and/or chemotherapy for advanced disease

• extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of bone marrow, e.g. whole of pelvis or half of spine)

• currently receiving oestrogen replacement therapy

• treatment with a non-approved or experimental drug within 4 weeks before enrolment

• absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no demonstrable liver metastases, or greater than 5 times the ULRR in the presence of liver metastases, history of bleeding diathesis or long term or present anticoagulant therapy (other than antiplatelet therapy

• any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy

• concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known

• severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• gefitinib and fulvestrant

Locations

Country	Name	City	State
Spain	Investigative Site	Alicante
Spain	Investigative Site	Gerona
Spain	Investigative Site	Jaen
Spain	Investigative Site	Madrid
Spain	Investigative Site	Seville
Spain	Investigative Site	Valencia
Spain	Investigative Site	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
Secondary	To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
Secondary	To estimate the disease control rate at trial closure.
Secondary	To estimate overall survival.
Secondary	To evaluate the safety & tolerability of the combination gefitinib and fulvestrant